Evaluation of Long Term Gadolinium Retention in HumanBone and Skin after the Retrospective MultiHance orProHance Administration in Comparison with theControl Group

Phase 1

• Conditions: ephrogenic Systemic Fibrosis (NSF); Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-000941-11-CZ
• Lead Sponsor: Bracco Imaging S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-26
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

SUBJECTS WHO RECEIVED MULTIHANCE or PROHANCE
•Is scheduled to receive hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
•Has undergone at least one MULTIHANCE or PROHANCE administration at least 1 month before his/her scheduled surgery
•Has a documented SCr for calculation of eGFR and/or documented eGFR at time of last MRI with MULTIHANCE or PROHANCE
•Provides written Informed Consent and is willing to comply with protocol requirements
•Is willing to undergo deep skin tissue sampling during scheduled hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
•Is =18 years of age

SUBJECTS WITH NO EXPOSURE TO GBCA
•Is scheduled to receive hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
•Has no history of GBCA administration
•Provides written Informed Consent and is willing to comply with protocol requirements
•Is willing to undergo deep skin tissue sampling during scheduled hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
•Has prior SCr and/or eGFR at time of enrollment
•Is =18 years of age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

SUBJECTS WHO RECEIVED MULTI HANCE or PROHANCE
Has undergone any GBCA including MULTIHANCE or PROHANCE administration less than 1 month before his/her scheduled surgery
Has ever been suspected of, or diagnosed with, NSF
Has been suspected or diagnosed, prior to inclusion in this study, with bone cancer or any other osteoblastic or osteoclastic disease, such as septic, infectious or ischemic disease affecting physiological bone structure that has caused the bone to be diseased, prior to inclusion in this study
Is unable or unwilling to be examined by dermatologists or to undergo laboratory/other diagnostic evaluations should development of NSF be suspected.
•Has received any GBCA other than the one under evaluation at any time prior to inclusion in this study (e.g., a MULTIHANCE subject should not receive any other GBCA including PROHANCE)

SUBJECTS WITH NO EXPOSURE TO GBCA
•Has received any GBCA at any time prior to inclusion in this study
•Has ever been suspected of, or diagnosed with, NSF prior to the enrollment
•Has been suspected or diagnosed with bone cancer or any other osteoblastic or osteoclastic disease, such as septic, infectious or ischemic disease affecting physiological bone structure that has caused the bone to be diseased prior to inclusion in this study
•Is unable or unwilling to be examined by dermatologists or to undergo laboratory/other diagnostic evaluations should development of NSF be suspected.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Not applicable;Primary end point(s): ;Main Objective: The objective of this study is to determine the long term Gd deposition in human bone and skin tissue (nmol Gd/g bone/skin) in subjects undergoing hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures following administration of MULTIHANCE or PROHANCE at least 1 month before their scheduled surgery in comparison with a control group receiving no exposure to Gd across different sub groups.